FDA 510(k) Application Details - K012906

Device Classification Name	Warmer, Thermal, Infusion Fluid   More FDA Info for this Device
510(K) Number	K012906
Device Name	Warmer, Thermal, Infusion Fluid
Applicant	ELLTEC CO., LTD. SHIRAKAWA NO. 6 BLDG. 2-18-5, NISHIKI, NAKA-KU NAGOYA 460-0003 JP Other 510(k) Applications for this Company
Contact	GENSHIRO OGAWA Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LGZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/29/2001
Decision Date	10/09/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review